NCT01542892

Efficacy of Nutritional Supplementation on Physical-activity Mediated Changes in Physical Functioning Older Adults at Risk for Mobility Disability (The VIVE2 Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

Summary

Several trials have found that nutritional supplementation can elicit an increased rate of skeletal muscle protein synthesis following a single bout of exercise in both young and older individuals. However, there have been no studies that have investigated if nutritional supplementation and exercise can cause a sustained increase in physical functioning and fat free mass, particularly in older adults with functional limitations. This study will compare the effects of a nutritional supplement versus a placebo on exercise training induced changes in physical functioning older adults who are at risk for mobility disability.

Detailed description

Exercise Intervention: Participants will complete exercise sessions 3 times per week for 6 months. The exercise sessions will involve walking, lower extremity strength exercises, flexibility, and balance training. Supplement Intervention: Participants will be randomly assigned to receive either the nutritional supplement or placebo. The participants will consume on beverage immediately after each exercise session. Primary Outcome: The primary outcome will be the time to walk 400 meters, expressed as average gait speed during the 400 M walk. All participants must be able to walk 400 meters in \<15 minutes at walking at their normal speed. The 400 M walk will be assessed at baseline, 3-months, and 6-months, with the changes at 6-months being the primary outcome. Secondary Outcome Measures: * Stair Climb Test * Body Composition * Skeletal muscle cross sectional area * Isokinetic/Isometric peak torque/power * Hand-grip strength * Nutritional status * Quality of Life/Depressive symptoms Expected enrollment: 150 (80 at Tufts University (Boston, MA, USA), 70 at University of Uppsala (Uppsala, Sweden))

Conditions

• Sarcopenia

Interventions

Type	Name	Description
OTHER	Exercise Intervention	Participants will complete exercise sessions 3 times per week for 6 months. The exercise sessions will involve walking, lower extremity strength exercises, flexibility, and balance training.
DIETARY_SUPPLEMENT	Supplement Intervention	Participants will be randomly assigned to receive either the nutritional supplement or placebo. The participants will consume on beverage immediately after each exercise session.

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2012-03-02
• Last updated: 2014-11-18

Locations

2 sites across 2 countries: United States, Sweden